SciaticaPhase 2ASASNCT00470509
Adalimumab in Severe and Acute Sciatica
A Phase 2 study testing Adalimumab in people with Sciatica, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
The purpose of this study is to determine whether adalimumab (a TNF-alpha inhibitor) is effective in the treatment of severe and acute sciatica. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sciatica
- What is being tested?
- Adalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2005to Jun 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients older than 18
- Episode of radicular pain in one lower limb for less than 12 weeks.
- Medical evaluation requiring hospitalisation because of pain or functional handicap
- Patients presenting a characteristic leg pain in the L3, L4, L5, or S1 territories plus at least one of the following: :
- positive straight-leg-raising test with an elevation of less than 70°
- positive femoral stretched
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- clear clinical sign of nerve root involvement
- muscle strength deficiency or
- sensory disturbances in clear cut dermatome or
- lower limb reflex asymmetry.
- Oswestry score greater than 50
- If there is a past history of radicular pain involving the same nerve root, a 6 months interval free of leg pain is required.
- A confirmed herniated disc on usual imaging techniques (CT scan or MRI) in the vicinity of the clinically involved nerve root that has been performed within the last 2 years.
- Written informed consent
Who cannot join
- The presence of recent (<48 hours) severe muscle weakness (<3/5) or clinical signs of cauda equina compression, requiring immediate surgery.
- If surgical procedure is required but is denied, either because of surgeon's decision or because of patient's fully informed decision, then this patient could be included in the protocol.
- Comorbidities such as :
- Coexisting infections (Chest X-ray will be performed to all patients and tuberculin skin test in case of doubt concerning a past history of tuberculous infection).
- Autoimmune disease (other than RA).
- History of cancer or malign lymphoproliferative disorders (unless the patient has been declared in remission for more than 5 years)
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- History of demyelinating disorders.
- Pregnancy.
- History of intolerance to adalimumab or any of its ingredients
- Previous participation in this clinical study.
- Participation in another clinical study within 4 weeks prior to the start of or during this study.
- Poor motivation or other emotional or intellectual problems that are likely to limit the ability of the patient to comply with the protocol requirements.
- The use of cortisone prior to the inclusion IS NOT an exclusion criteria
- The investigators will also be allowed to exclude an individual patient from the study and remove the blinding in case of a superimposed infection or any severe side effect during the trial.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether adalimumab (a TNF-alpha inhibitor) is effective in the treatment of severe and acute sciatica.
Read the detailed description
Sciatica and low back pain are common problems that lead to major costs in Western countries. The presence of herniated disc is generally considered as the leading cause of sciatica. However, recent findings indicate that the presence of this mechanism is not sufficient to explain all the clinical signs of radiculopathy and that inflammatory mechanisms contribute also to the pathophysiology of sciatica. Indeed, herniated discs contain large amounts of tumor necrosis factor (TNF-alpha) which can induce acute and chronic inflammation and pain. It has recently been demonstrated that TNF-alpha inhibitors (infliximab or etanercept) were able to prevent the occurrence of pain in an experimental model of sciatica. In addition, two independent preliminary studies have shown that patients treated with TNF-alpha inhibitors had better evolution than an historical control group. This study has been designed to verify the hypothesis that TNF-alpha has a major role in human sciatica and that anti-TNF-alpha agents are interesting therapeutic approaches in severe sciatica.
- Conditions
- Sciatica
- Being tested
- Adalimumab, Placebos
- Medical subject headings
- Sciatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabDrug
Also called Humira
2 subcutaneous injections on day 0 and 7
PlacebosDrug
Also called placebo injection
2 subcutaneous injections on day 0 and 7
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab | Experimental | adalimumab (2 subcutaneous 40 mg injections on day 0 and 7) Receives: Drug: Adalimumab |
| Placebo | Placebo comparator | 2 placebo injections on day 0 and 7 Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leg pain
Evolution of leg pain over time. Pain will be assessed using a Visual Analog Scale (VAS).
Measured: 6 months
Secondary outcomes (3)
delta VAS
Percentage of amelioration for VAS and ODI (Oswestry Disability Index)
Measured: 6 months
SF-12
Assessment of patient's statisfaction and expectations using the SF12 general health questionnaire.
Measured: 6 months
delta ODI
Percentage of amelioration for ODI (Oswestry Disability Index)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2007 (estimated)
- Study startMay 2005
- Primary completionJan 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SciaticaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephane Genevay, University Hospital, Geneva
- Investigators
- Stéphane Genevay, MD, Principal investigator, Geneva University Hospital & Swiss Society of Rheumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00470509
- Sponsor's protocol ID
- ASAS
- Acronym
- ASAS
- Status last verified
- Apr 2019
- First submitted
- 4 May 2007
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Genevay S, Viatte S, Finckh A, Zufferey P, Balague F, Gabay C. Adalimumab in severe and acute sciatica: a multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2010 Aug;62(8):2339-46. doi: 10.1002/art.27499.
PubMed 20506391
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adalimumab in Severe and Acute Sciatica
- ClinicalTrials.gov ID
- NCT00470509
- Acronym / sponsor ID
- ASAS / ASAS
- Conditions
- Sciatica
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 7 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether adalimumab (a TNF-alpha inhibitor) is effective in the treatment of severe and acute sciatica.
Detailed description
Sciatica and low back pain are common problems that lead to major costs in Western countries. The presence of herniated disc is generally considered as the leading cause of sciatica. However, recent findings indicate that the presence of this mechanism is not sufficient to explain all the clinical signs of radiculopathy and that inflammatory mechanisms contribute also to the pathophysiology of sciatica. Indeed, herniated discs contain large amounts of tumor necrosis factor (TNF-alpha) which can induce acute and chronic inflammation and pain. It has recently been demonstrated that TNF-alpha inhibitors (infliximab or etanercept) were able to prevent the occurrence of pain in an experimental model of sciatica. In addition, two independent preliminary studies have shown that patients treated with TNF-alpha inhibitors had better evolution than an historical control group. This study has been designed to verify the hypothesis that TNF-alpha has a major role in human sciatica and that anti-TNF-alpha agents are interesting therapeutic approaches in severe sciatica.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adalimumab | Experimental | Drug: Adalimumabadalimumab (2 subcutaneous 40 mg injections on day 0 and 7) |
| Placebo | Placebo comparator | Drug: Placebos2 placebo injections on day 0 and 7 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female patients older than 18
- Episode of radicular pain in one lower limb for less than 12 weeks.
- Medical evaluation requiring hospitalisation because of pain or functional handicap
- Patients presenting a characteristic leg pain in the L3, L4, L5, or S1 territories plus at least one of the following: :
- Oswestry score greater than 50
Key exclusion criteria (14 listed)
- The presence of recent (<48 hours) severe muscle weakness (<3/5) or clinical signs of cauda equina compression, requiring immediate surgery.
- Comorbidities such as :
- Pregnancy.
- History of intolerance to adalimumab or any of its ingredients
- Previous participation in this clinical study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdalimumabAlso: Humira2 subcutaneous injections on day 0 and 7 | Drug | Adalimumab |
| PlacebosAlso: placebo injection2 subcutaneous injections on day 0 and 7 | Drug | Placebo |
Primary outcome
Leg pain
Time frame: 6 months
Evolution of leg pain over time. Pain will be assessed using a Visual Analog Scale (VAS).
3 secondary outcomes
delta VAS
Time frame: 6 months
SF-12
Time frame: 6 months
delta ODI
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
- Derived from this study: PubMed 20506391Genevay S, Viatte S, Finckh A, Zufferey P, Balague F, Gabay C. Adalimumab in severe and acute sciatica: a multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2010 Aug;62(8):2339-46. doi: 10.1002/art.27499.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphane Genevay, MD principal investigator
Geneva University Hospital & Swiss Society of Rheumatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adalimumab in people with Sciatica, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leg pain (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00470509, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2019.